Clip syringe

ABSTRACT

A single use pre-filled delivery device is disclosed having a deformable container including a side wall having an inside surface defining a chamber for retaining fluid, a clip element, and a locking element. The deformable container further includes a closed proximal end and an open distal end including a male luer tip having a passageway therethrough providing fluid communication with the chamber. The male luer tip may be removably connectable to a female luer connection of a vascular access device. The clip element includes a distal end, proximal end, and a pivot located between the distal end and the proximal end of the clip element for collapsing the deformable container to drive fluid out of the chamber by movement of the proximal end towards the distal end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application No. 61/664,443, filed Jun. 26, 2012, thedisclosures of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

An aspect of the invention relates generally to a single use pre-filleddelivery device having a deformable container including a side wallhaving an inside surface defining a chamber for retaining fluid, aclosed proximal end and an open distal end including a male luer tiphaving a passageway therethrough providing fluid communication with saidchamber; said male luer tip removably connectable to a female luerconnection of a vascular access device; and a clip element forcollapsing the deformable container having a distal end and proximal endcomprising a pivot located between the distal end and the proximal endfor driving fluid out of said chamber by movement of the proximal endtowards the distal end, the clip element comprising a distal portion anda proximal portion, said deformable container being attached to the clipelement; and a locking element disposed on the clip element. Anotheraspect of the invention relates generally to a method of flushing oradministering a fluid using the single use pre-filled delivery devicedescribed herein.

BACKGROUND

Vascular access devices (VAD) used to access a patient's vascular spacewithout puncture using a hypodermic needle. Vascular Access Devices(VADs) include intravenous catheters, syringes, extension sets, stopcocks, tubing, high pressure extension tubing, and needleless accessdevices. These devices are used in patients where frequent access isrequired to the vascular space for delivery of treatment and withdraw offluids. Indwelling vascular access devices are susceptible to infectionand occlusion, requiring continued preventive maintenance. To ensureVADs are used properly and do not become occluded, standards of practicehave been developed to maintain the indwelling VAD. These standardsinclude a cleaning procedure, which is commonly referred to as a flushprocedure. One form of VAD maintenance is a continuous saline dip wherewhich a saline bag is connected to the VAD and provides continuous flowof saline solution to the patient through the VAD. This approach may putthe patient at risk by delivering excess fluid to the vascular space.

An alternative method for vascular device maintenance, known asflushing, involves intermittent delivery of saline thru the VAD using ahypodermic syringe. One way to deliver intermittent saline to the VAD isto fill a hypodermic syringe fitted with a needle from a saline vial orampoule. The filled syringe is then connected to the VAD and the salineis then flushed thru the VAD into the patient. Use of pre-filled salineflush syringes to deliver saline flush to VAD's offers improved safetyand efficiency over manually filled hypodermic syringes.

It is important in the flush procedure not to draw blood back into thecatheter where it can clot and seal the catheter, commonly referred toas “reflux”. In order to prevent blood reflux into the catheter the useris encouraged to maintain a positive pressure in the line during theflush procedure. This may involve clamping the IV line and withdrawingthe syringe and cannula from the LV. port while still applying pressureto the syringe plunger rod during the flush procedure. When using aconventional syringe with an elastomeric stopper, the stopper is oftencompressed when it contacts the distal end of the syringe barrel at thecompletion of the flush procedure. When a user relieves the pressure tothe plunger after the flush procedure is completed, the stopper willexpand back to its normal size thereby withdrawing liquid from thecatheter into the syringe barrel. This is undesirable, since it cancause blood to enter the catheter at the catheter distal end (reflux)where it will remain stationary until the next time the VAD is used.

Although a wide variety of catheters and I.V. ports can be adequatelyflushed using currently available syringe assemblies, as flushingpractices change from continuous IV drip to intermittent flushing, thereis a need for a new sterile, single use, pre-filled delivery device formaintenance of VAD's.

SUMMARY

Embodiments of the present invention are directed to a single usepre-filled delivery device having a deformable container, including aside wall having an inside surface defining a chamber for retainingfluid; a clip element; and a locking element. The deformable containerfurther includes a closed proximal end and an open distal end includinga male luer tip having a passageway therethrough providing fluidcommunication with the chamber. The deformable container may be made ofthermoplastic elastomers, polyolefin, polyester or other injectionmoldable or formable resin. Thermoplastic elastomers include, but arenot limited to, polypropylene, polyethylene and the like. The male luertip may be removably connectable to a female luer connection of avascular access device. The clip element includes a distal end, proximalend, and a pivot located between the distal end and the proximal end ofthe clip element for collapsing the deformable container to drive fluidout of the chamber by movement of the proximal end towards the distalend. In one or more embodiments, the pivot may be a hinge, which may bein the form of a living hinge. The deformable container may be attachedto the clip element. The locking element may be disposed on the clipelement.

In one or more embodiments, the single use pre-filled delivery devicefurther includes a tip cap that is releasably connected to the male luertip of the deformable container for sealing the passageway.

In one or more embodiments, the vascular access device is a syringe,extension set, intravenous set, stop cock, tubing, high pressureextension tubing, or needleless connector.

In one or more embodiments, the single use pre-filled delivery devicefurther includes a pre-selected amount of fluid in the chamber. Thepre-selected amount of fluid in the chamber may be from 0.5 ml to 10 ml.In one or more embodiments, the fluid may include a medicament, drug orflush solution, such as saline solution.

The locking element of the present invention minimizes, limits orprevents reflux of solution in the passageway. The locking element alsoprovides confirmation to the user of solution delivery by providingfeedback to the user to confirm delivery of a desired volume of fluidfrom the chamber. The feedback may be tactile, visual or audible. In oneor more embodiments, the locking element includes at least oneprotrusion and at least one corresponding cavity. In one or moreembodiments, the at least one protrusion is disposed on the proximal endof the clip element and the corresponding cavity is disposed on thedistal end of the clip element. In another embodiment, the at least oneprotrusion is disposed on the distal end of the clip element and the atleast one corresponding cavity is disposed on the proximal end of theclip element. The locking element is arranged to be manually activatedby a user after the protrusion engages to the corresponding cavity afterthe fluid has been expelled from the deformable container. In analternate embodiment of the present invention, the locking elementincludes detents. In yet another alternate embodiment of the presentinvention, the locking element includes a ratcheting mechanism having aplurality of teeth and a catch. In one embodiment, the catch is disposedon the proximal end of the clip element and the plurality of teeth isdisposed on the distal end of the clip element. In another embodiment,the catch is disposed on the distal end of the clip element and theplurality of teeth is disposed on the proximal end of the clip element.The locking element is arranged to be manually activated by a user afterthe catch engages to one or more of the plurality of teeth.

In yet another alternate embodiment of the present invention, thelocking element includes a snap fit element to connect the distal end ofthe clip element to the proximal end of the clip element upon therelease.

In one embodiment, the pivot is positioned on the proximal end of thedeformable container. In another embodiment, the pivot is positioned onthe distal end of the deformable container. The pivot may be oriented ina perpendicular position with respect to the distal end of thedeformable container.

In one or more embodiments, the clip element further includes at leastone protrusion for removing one or more air bubbles from the deliverydevice and controlling the delivery of fluid from the delivery device.

In an alternate embodiment of the present invention, a single usepre-filled delivery device having a deformable container includes a sidewall having an inside surface defining a chamber for retaining fluid, aclosed proximal end and an open distal end including a male luer tiphaving a passageway therethrough providing fluid communication with saidchamber, a three-fold clip element and a locking element. The male luertip is removably connectable to a female luer connection of a vascularaccess device. The three-fold clip element includes a first portion, asecond portion and third portion. The deformable container may beattached to the first portion of the clip element. The second portion ofthe clip element may be attached to the first portion by a first pivot.The second portion of the clip element is foldable over the firstportion of the clip element for removing one or more air bubbles fromthe deformable container. The third portion is attached to the secondportion by a second pivot, and the third portion of the clip element isfoldable over the first portion of the clip element for driving fluidout of said chamber. The locking element may be disposed on the firstand third portion of the clip element.

Another aspect of the present invention pertains to a method of flushingor administering a fluid to a vascular access device comprisingproviding a single use pre-filled delivery device as described herein;providing a vascular access device having a proximal end, a distal endand a passageway therethrough, said proximal end having a female luertip in fluid communication with said passageway; placing said distal endof said vascular access device in a blood vessel of a patient; engagingsaid male luer tip of said deformable container with said female luertip of said vascular access device; applying force to said clip elementto deform the collapsible container so that said flush solution in saidchamber flows through said passageway into said vascular access device;continuing to apply force to the clip element until said distal end ofthe locking element engages the said proximal end of the lockingelement; and disengaging said male luer tip of said deformable containerfrom said female luer tip of said vascular access device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating one embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 2 is a perspective view illustrating a second embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 3 is a perspective view illustrating a third embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 4 is a perspective view illustrating a fourth embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 5 is a perspective view illustrating a fifth embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 6 is a perspective view illustrating a sixth embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 7 is a perspective view illustrating a seventh embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 8 is a perspective view illustrating an eighth embodiment of thesingle use pre-filled delivery device of the present invention having atip cap.

FIG. 9 is a top view illustrating an eighth embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 10 is a right side view illustrating an eighth embodiment of thesingle use pre-filled delivery device of the present invention having atip cap.

FIG. 11 is a bottom view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 12 is a side view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 13 is a back view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 14 is a front view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 15 is a side view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 16 is a side view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 17 is a side view illustrating an eighth embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

DETAILED DESCRIPTION OF THE INVENTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

The term “deformable” refers to a wall or container that is structuredto be flexible enough to collapse at least partially into the innerchamber under manual depression. The shape and extent of the deformationwill vary with the various configurations of the inner chamber anddeformable container.

As used herein, the term “luer” with respect to a connector, connectionor tip refers to a connection collar that is the standard way ofattaching syringes, catheters, hubbed needles, IV tubes, etc. to eachother. The luer connection consists of male and female interlockingtubes, slightly tapered to hold together better with even just a simplepressure/twist fit. Luer connectors can optionally include an additionalouter rim of threading, allowing them to be more secure. The luerconnector male end is generally associated with a delivery device andcan interlock and connect to the female end located on a vascular accessdevice (VAD). A luer connector comprises a distal end, a proximal end,an irregularly shaped outer wall, a profiled center passageway for fluidcommunication from the chamber of the barrel of a syringe to the hub ofa VAD. A luer connector also has a distal end channel that releasablyattaches the luer connector to the hub of a VAD, and a proximal endchannel that releasably attaches the luer connector to the barrel of asyringe.

The single use pre-filled delivery device of the present invention isshown in FIGS. 1-7. A single use sterile delivery device of the presentinvention reduces the risk associated with contamination due to manuallyfilling a syringe with flush solution or medicament from a vial.Generally speaking, the single use device of the present inventioncapable of delivering sterile solution to the female luer connection ofa VAD. In general, the device comprises a deformable container with amale luer connector capable of holding between 0.5 mL and 10 mL ofsterile solution and a clip element that collapses the deformablecontainer to expel the solution within. The deformable containerincludes a male luer connector that enables secure connection to thefemale luer connector within a VAD. The clip element contains a pivotwhich is activated by pressing the moveable sides together to expel thesolution from the deformable container.

Referring to FIG. 1, a single use pre-filled delivery device 10according to the present invention generally comprises a deformablecontainer 20 including a side wall 21 having an inside surface 22defining a chamber 23 for retaining fluid, a clip element 30, and alocking element 40. In operation, delivery device 10 is attached to apatient's catheter via a patient's vascular access device (VAD). Thedeformable container 20 further comprises a closed proximal end 24 andan open distal end 25 including a male luer tip 26 having a passageway27 therethrough providing fluid communication with the chamber 23. Themale luer tip 26 may be removably connectable to a female luerconnection of a vascular access device. Thus, the delivery device of thepresent invention is capable of a generating a secure connection with areceiving needleless female vascular access connector. The clip element30 comprises a distal end 31, proximal end 32, and a pivot 33 locatedbetween the distal end 31 and the proximal end 32 of the clip element 30for collapsing the deformable container 20 to drive fluid out of thechamber 23 by movement of the proximal end 32 towards the distal end 31.In one or more embodiments, the pivot 33 may be a hinge, which may be inthe form of a living hinge. The deformable container 20 may be attachedto the clip element 30. The locking element 40 may be disposed on theclip element 30.

One advantage of the present invention over prior is that the clipelement 30 of the present invention improves control of fluid deliveryfrom the deformable container 20.

In one or more embodiments, the single use pre-filled delivery device 10further includes a tip cap 45 that is releasably connected to the maleluer tip 26 of the deformable container 20 for sealing the passageway27. FIGS. 8-17 show an embodiment of the single use pre-filled deliverydevice 10 of the present invention having a tip cap 45.

In one or more embodiments, the vascular access device is a syringe,extension set, intravenous set, stop cock, tubing, high pressureextension tubing, or needleless connector.

In one or more embodiments, the single use pre-filled delivery device 10further includes a pre-selected amount of fluid in the chamber 23. Thepre-selected amount of fluid in the chamber 23 may be from 0.5 ml to 10ml. In one or more embodiments, the fluid may include a flush solutionor a medicament. The flush solution may be any solution intended forflushing or maintaining performance of VAD's. The flush solution may beselected from the group consisting of saline flush solution, water,heparin flush solution or a combination thereof. These solutions areknown in the art and are readily available. The single-use deliverydevice 10 is pre-filled with flush solution during or after the assemblyof the syringe using sterile filling methods. Such prefilled assembliesmay be supplied with a tip cap 45 that seals the passageway 27 of thedeformable container 20 and male luer tip 26. The tip cap may be isformed of material selected from a group of thermoplastic materials andelastomeric materials such as natural and synthetic rubber,thermoplastic elastomers, polyolefin, polyester or other injectionmoldable or formable resin, combinations thereof, or other easilydisposable and/or recyclable material. Thermoplastic elastomers include,but are not limited to, polypropylene, polyethylene and the like. Onceassembled, the syringe assembly may be used in flushing or administeringa fluid to a VAD such as a catheter of an I.V. set.

The locking element 40 of the present invention minimizes, limits orprevents reflux of solution in the passageway 27. The locking element 40also provides confirmation to the user of solution delivery. In one ormore embodiments, the locking element 40 includes at least oneprotrusion and at least one corresponding cavity. In one or moreembodiments, the at least one protrusion is disposed on the proximal end32 of the clip element 30 and the corresponding cavity is disposed onthe distal end 31 of the clip element 30. In another embodiment, the atleast one protrusion is disposed on the distal end 31 of the clipelement 30 and the at least one corresponding cavity is disposed on theproximal end 32 of the clip element 30. The locking element 40 isarranged to be manually activated by a user after the protrusion engagesto the corresponding cavity after the fluid has been expelled from thedeformable container 20. When the entire contents of the inner chamber23 are expelled and the protrusion is in contact and engages with thecavity to locks the proximal end 32 of the clip element 30 to the distalend 31 of the clip element 30.

In one or more alternative embodiments, detents or tabs on the lockingelement 40 may be used to retain the proximal end 32 of the clip element30 to the distal end 31 of the clip element 30.

In an alternate embodiment of the present invention, the locking element40 includes a ratcheting mechanism having a plurality of teeth and acatch. In one embodiment, the catch is disposed on the proximal end 32of the clip element 30 and the plurality of teeth is disposed on thedistal end 31 of the clip element 30. In another embodiment, the catchis disposed on the distal end 31 of the clip element 30 and theplurality of teeth is disposed on the proximal end 32 of the clipelement 30. The locking element 40 is arranged to be manually activatedby a user after the catch engages to one or more of the plurality ofteeth.

In an alternate embodiment of the present invention, the locking element40 includes a snap fit element to connect the distal end 31 of the clipelement 30 to the proximal end 32 of the clip element 30 upon therelease.

In one embodiment, the pivot 33 is positioned on the proximal end 24 ofthe deformable container 20. In another embodiment, the pivot 33 ispositioned on the distal end 25 of the deformable container 20. Thepivot 33 may be oriented in a perpendicular position with respect to thedistal end 25 of the deformable container 20.

The locking element 40 enables the clip element 30 to be secured inplace after the solution has been expelled. The locking element 40 alsolimits reflux of solution in the fluid path of the vascular access. Thelocking element 40 provides feedback to the user to confirm delivery ofa desired volume of fluid from the chamber 23. The feedback may betactile, visual or audible.

The materials for the deformable container 20 will have to be chosenbased not only on performance but on compatibility with the injectableliquid. In a preferred embodiment the single use pre-filled deliverydevice 10 is prefilled with injectable liquid. There may be asubstantial amount of time between when the delivery device 10 is filledand when the contents of the delivery device 10 are delivered.Accordingly, materials chosen for delivery device 10 may have to bestable under long term storage.

The deformable container 20, clip element 30 and locking element 40 maybe made of thermoplastic elastomers, polyolefin, polyester or otherinjection moldable or formable resin, natural rubber, synthetic rubber,thermoplastic materials, or other easily disposable and/or recyclablematerial and combinations thereof. Thermoplastic elastomers include, butare not limited to, polypropylene, polyethylene and the like. Materialsshould be chosen to be compatible with the solution, medicament andmanufacturing process being used. It is envisioned that in one or moreembodiments, the delivery device of the present invention may be made ofa single material to facilitate recycling of the device.

In one or more embodiments, the clip element 30 further includes atleast one protrusion 35 for removing one or more air bubbles from thedelivery device 10 and controlling the delivery of fluid from thedelivery device 10.

There are several embodiments of the orientation of the clip element 30.As shown in FIG. 1, the delivery device 10 comprises one pivot 33positioned opposite of the male luer tip of the deformable container 20between the proximal end and distal end of the clip element 30. As shownin FIG. 2, the delivery device 10 comprises a locking element 60 havinga forked tip on the proximal end of the clip element which engages thedistal end of the clip element near the male luer tip upon activation.As shown in FIG. 2, the delivery device 10 comprises a V-shaped clipelement having one pivot 33 positioned mid-way along the clip elementnear of the male luer tip of the deformable container 20. The deliverydevice 10 may include a frangible seal 51 to close the passageway of thechamber 23. As shown in FIG. 2, the delivery device 10 comprises alocking element 40 having a protrusion on the distal end of the clipelement which engages a cavity on the proximal end of the clip element.As shown in FIGS. 3-5, the delivery device comprises a deformablecontainer positioned in between a V-shaped clip element, said V-shapedclip element comprising two flat longitudinal surfaces 70 connected bypivot 33 positioned perpendicular to the male luer tip located on thedistal end of the deformable container. As shown in FIG. 3, in oneembodiment, the locking element includes a protrusion 80 on onelongitudinal end of the clip element which engages a correspondingcavity 90 located on the opposite end of the clip element. As shown inFIG. 4, in one embodiment, the locking element includes a plurality ofteeth 92 on one longitudinal end of the clip element which engages acorresponding catch 94 located on the opposite end of the clip element.As shown in FIG. 5, in one embodiment, the locking element includesdetents or a tab 98 on one longitudinal end of the clip element whichengages a corresponding slot or cavity 99 located on the opposite end ofthe clip element. The embodiments of FIGS. 1-5 are activated by pressingthe moveable distal and proximal ends of the clip element together toactivate the device and deliver the contents.

As shown in FIG. 6, the delivery device 10 comprises two pivots 33 and34 to create a three-fold clip element comprising portions A, B and C.Pivot 33 connects portions A and B. Pivot 34 connects portions B and C.Deformable container 20 is attached to portion A. Upon activation,portion B folds upon the proximal end of portion A via pivot 33 to servea priming function for the removal of air bubbles from deformablecontainer 20. Portion C folds upon portion A via pivot 34 for theexpulsion of fluid from deformable container 20.

As shown in FIG. 7, the delivery device 10 comprises one pivot 33 tocreate a two-fold clip element, i.e. plate element, comprising a firstportion “A” and a second portion “B”. Pivot 33 allows movement of thefirst portion “A” and a second portion “B” of the clip element in anaxial direction in a clockwise or counter-clockwise direction. When thedelivery device is being held by a user, the clip element is movable bythe user along pivot 33 in a counter-clockwise direction, such thatfirst portion A contacts and compresses the deformable container andserves a priming function for the removal of air bubbles from deformablecontainer 20. When the clip element moves along pivot 33 in a clockwisedirection, second portion B of clip element compresses the deformablecontainer and serves to expel fluid from deformable container 20. Asshown in FIG. 7, locking element 40 is in the form of a detent or tabwhich engages a recess 41.

Additional embodiments are possible in which the clip element 30 of thedevice includes features which allow for additional control of thevolume and rate of fluid expelled from the device. In one embodiment,the moveable clip element contains protrusions 35, which control thedelivery of solution volume for priming the syringe for use and deliveryof the remaining solution. The term “priming” is defined as the removalof the air bubble. Two additional embodiments include an embodiment withthe protrusion 35 on one side of the clip, as shown in FIG. 6, and onboth sides of the clip elements, as shown in FIG. 7.

In an alternate embodiment, single use pre-filled delivery device 10comprises a deformable container including a side wall having an insidesurface defining a chamber for retaining fluid, a closed proximal endand an open distal end including a male luer tip having a passagewaytherethrough providing fluid communication with said chamber, athree-fold clip element and a locking element. The male luer tip isremovably connectable to a female luer connection of a vascular accessdevice. The three-fold clip element includes a first portion, a secondportion and third portion. The deformable container may be attached tothe first portion of the clip element. The second portion of the clipelement may be attached to the first portion by a first pivot. Thesecond portion of the clip element is foldable over the first portion ofthe clip element for removing one or more air bubbles from thedeformable container. The third portion is attached to the secondportion by a second pivot, and the third portion of the clip element isfoldable over the first portion of the clip element for driving fluidout of said chamber. The locking element may be disposed on the firstand third portion of the clip element.

The delivery device 10 of the present invention may be used inconjunction with a vascular access device having a proximal end, adistal end and a passageway 27 therethrough, said proximal end having afemale luer tip in fluid communication with said passageway 27. To usethe delivery device 10 in a flushing procedure or to administering afluid, the user engages the male luer tip 26 of the deformable container20 of the delivery device 10 with the female luer tip of a vascularaccess device, after the distal end of said vascular access device hasbeen placed in a blood vessel of a patient. The user then applies forceto the clip element 30 to deform the collapsible container 20 so thatsaid flush solution in said chamber 23 flows through said passageway 27into said vascular access device. The user continues to apply force tothe clip element 30 until said distal end 41 of the locking element 40engages the said proximal end 42 of the locking element 40. After theexpulsion of the desired amount of fluid from the chamber 23, the userdisengages said male luer tip 26 of said deformable container 20 fromsaid female luer tip of said vascular access device. One advantage ofthe present invention is that the delivery device of the presentinvention collapses to a configuration with minimal dead space andsecures using the locking element 40. Another advantage of the presentinvention is that the moveable clip element 30 allows the user to sensethe resistance in the fluid path, wherein increased resistance couldallow the operator to detect resistance within the components of thedelivery device or vascular access device.

The device of the present invention may be produced as a singlecomponent or as multiple parts assembled in a second step. As a singlecomponent, the clip element 30, deformable container 20 and lockingelement 40 are incorporated into a single part. In the multiplecomponent configuration, the clip element 30, deformable container 20and locking element 40 may be formed from any number of individual partsand assembled together.

The single use pre-filled delivery device 10 of the present inventionmay be manufactured in accordance with a blow-fill-seal technique of acharacter well understood by those skilled in the art.

The concept of a blow-fill-seal process is that a container is formed,filled, and sealed as a unitary container in a continuous manner withouthuman intervention in a sterile, enclosed area inside a machine.Blow-fill-seal manufacturing forms a closed container by extruding andforming a parison within a mold, filling the container and sealing thecontainer in a single step. This manufacturing process enables thedevice to be produced in a single process. For example, pharmaceuticalgrade resin is extruded into a tube, which is then formed into acontainer. A mandrel is inserted into the newly formed container andfilled. The container is then sealed, all inside a sterile, shroudedchamber. The product is then discharged to a non-sterile area forpackaging and distribution. This blow-fill-seal technique comprises thecontinuous extrusion through an extruder head of a length of a parisonin the form of a hollow tube between and through two co-acting first ormain mold halves. The method includes the step of cutting off theparison below the extruder head and above the main mold halves to createan opening which allows a blowing and filling nozzle assembly to bemoved downwardly into the opening in the parison for molding andthereafter filling a molded container. When the container portion of thecontainer assembly is filled with the desired amount of liquid, theblowing and filling nozzle assembly is retracted from the opening in theparison. A separate pair of co-acting second or upper sealing moldhalves are then moved together around the exposed length of parison toform and seal the container upper portion. The finished containerassembly, completely formed, filled, and sealed as a unitary structureis then conveyed out of the molding apparatus.

A single use, pre-filled, sterile delivery device of the presentinvention reduces the risk associated with contamination due to manualfilling a syringe with flush solution or medicament from a vial.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A single use pre-filled delivery devicecomprising: a deformable container including a side wall having aninside surface defining a chamber for retaining fluid, a closed proximalend and an open distal end including a male luer tip having a passagewaytherethrough providing fluid communication with said chamber; said maleluer tip removably connectable to a female luer connection of a vascularaccess device; and a plate element for collapsing the deformablecontainer having a distal end and proximal end comprising a pivotlocated at the proximal end, the plate element comprising a firstportion and a second portion, said deformable container being attachedto the plate element at the pivot, wherein when the delivery device isbeing held by a user, the plate element being movable by the user alongthe pivot in a counter-clockwise direction to allow the first portion ofthe plate element to contact a side wall of the deformable container toremove one or more air bubbles, and subsequently the plate element beingmovable by the user along the pivot in a clockwise direction to allowthe second portion of the plate element to collapse the deformablecontainer to expel a fluid from the chamber; and a locking elementcomprising at least one detent that engages with at least onecorresponding recess on the side wall of the deformable container. 2.The single use pre-filled delivery device of claim 1, wherein the pivotis a hinge.
 3. The single use pre-filled delivery device of claim 2,wherein the hinge is a living hinge.
 4. The single use pre-filleddelivery device of claim 1, further including a tip cap releasablyconnected to said male luer tip of said deformable container for sealingsaid passageway.
 5. The single use pre-filled delivery device of claim1, wherein the vascular access device is a syringe, extension set,intravenous set, stop cock, tubing, high pressure extension tubing, orneedleless connector.
 6. The single use pre-filled delivery device ofclaim 1, further comprising a pre-selected amount of sterile fluid inthe chamber.
 7. The single use pre-filled delivery device of claim 6,wherein the pre-selected amount of fluid in the chamber is from 0.5 mlto 10 ml.
 8. The single use pre-filled delivery device of claim 6,wherein the fluid comprises a medicament or drug.
 9. The single usepre-filled delivery device of claim 6, wherein the fluid comprises asterile flush solution.
 10. The single use pre-filled delivery device ofclaim 9, wherein the flush solution is saline, heparin, water or acombination thereof.
 11. The single use pre-filled delivery device ofclaim 1, wherein the locking element minimizes reflux of solution in thepassageway.
 12. The single use pre-filled delivery device of claim 1,wherein the locking element provides confirmation to the user ofcomplete solution delivery when the detent of the locking elementengages with the at least one corresponding recess on the side wall ofthe deformable container.
 13. The single use pre-filled delivery deviceof claim 1, wherein the locking element is arranged to be manuallyactivated by a user after the detent engages to the at least onecorresponding recess on the side wall of the deformable container afterthe fluid has been expelled from the deformable container.
 14. Thesingle use pre-filled delivery device of claim 1, wherein the pivot ispositioned on the proximal end of the deformable container.
 15. Thesingle use pre-filled delivery device of claim 1, wherein the pivot ispositioned on the distal end of the deformable container.
 16. The singleuse pre-filled delivery device of claim 1, wherein the pivot is orientedin a perpendicular position with respect to the distal end of thedeformable container.
 17. The single use pre-filled delivery device ofclaim 1, wherein the locking element provides feedback to the user uponthe detent engaging the at least one corresponding recess to confirmdelivery of the fluid from the chamber.
 18. The single use pre-filleddelivery device of claim 17, wherein the feedback is tactile, visual oraudible.
 19. The single use pre-filled delivery device of claim 1,wherein the deformable container is made of thermoplastic elastomers,polyolefin, polyester or other injection moldable or formable resin.